ID

36740

Beschreibung

Phase II Study of KPT-330 (Selinexor) in Female Patients With Advanced Gynaecologic Malignancies & Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02025985

Link

https://clinicaltrials.gov/show/NCT02025985

Stichworte

Versionen (1)
  1. 05.06.19 05.06.19 -
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See clinicaltrials.gov

Hochgeladen am

5. Juni 2019

DOI

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Eligibility Ovarian Carcinoma NCT02025985

Englisch

Eligibility Ovarian Carcinoma NCT02025985

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
ovarian, fallopian tube or peritoneal carcinoma: both platinum refractory and platinum resistant patients, who have received ≥ 1 lines of chemotherapy for relapsed disease (i.e., ≥2 lines of chemotherapy in total).
Beschreibung

Ovarian Carcinoma | Fallopian Tube Carcinoma | Carcinoma of peritoneum | Patients Unresponsive to Platinum | Patients Resistant to Platinum | Chemotherapy Quantity Recurrent disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0029925
UMLS CUI [2]
C0238122
UMLS CUI [3]
C0948303
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0205269
UMLS CUI [4,3]
C0032207
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C0332325
UMLS CUI [5,3]
C0032207
UMLS CUI [6,1]
C0392920
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C0277556
endometrial carcinoma: patients must have received ≥ 1 line of chemotherapy for relapsed or advanced (stage iv, iiic) disease.
Beschreibung

Endometrial Carcinoma | Chemotherapy Quantity | Recurrent disease TNM clinical staging | Advanced disease TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0476089
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C3258246
UMLS CUI [4,1]
C0679246
UMLS CUI [4,2]
C3258246
cervical carcinoma: patients must have received ≥ 1 lines of chemotherapy for relapsed or advanced (stage ivb) disease.
Beschreibung

Cervix carcinoma | Chemotherapy Quantity | Recurrent disease | Advanced disease TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C0302592
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0277556
UMLS CUI [4,1]
C0679246
UMLS CUI [4,2]
C3258246
breast cancer: adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection or any other curative treatment.
Beschreibung

Breast Carcinoma | Breast adenocarcinoma | Neoplasm Metastasis Inappropriate Excision | Advanced disease Locally Inappropriate Excision | Neoplasm Metastasis Inappropriate Curative treatment | Advanced disease Locally Inappropriate Curative treatment

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0858252
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C0728940
UMLS CUI [4,1]
C0679246
UMLS CUI [4,2]
C1517927
UMLS CUI [4,3]
C1548788
UMLS CUI [4,4]
C0728940
UMLS CUI [5,1]
C0027627
UMLS CUI [5,2]
C1548788
UMLS CUI [5,3]
C1273390
UMLS CUI [6,1]
C0679246
UMLS CUI [6,2]
C1517927
UMLS CUI [6,3]
C1548788
UMLS CUI [6,4]
C1273390
breast cancer: patients must have received ≥ 1 line of endocrine treatment or chemotherapy for metastatic disease as applicable for the respective breast cancer subtype.
Beschreibung

Breast Carcinoma | Hormone Therapy Quantity Neoplasm Metastasis | Chemotherapy Quantity Neoplasm Metastasis

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027627
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0027627
breast cancer: patient must have either triple negative cancer or be hormone receptor positive (i.e., er+ and/or pr+) and her2 negative.
Beschreibung

Breast Carcinoma | Triple Negative Breast Neoplasms | Hormone receptor positive tumor | Oestrogen receptor positive breast cancer | Progesterone receptor positive tumor | HER2 negative carcinoma of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C3539878
UMLS CUI [3]
C1563119
UMLS CUI [4]
C2938924
UMLS CUI [5]
C1562928
UMLS CUI [6]
C2316304
must have either measurable disease (recist 1.1) or evaluable disease outside irradiated field on ct/mri. a rise in ca-125 or other tumor marker alone is not sufficient.
Beschreibung

Measurable Disease | Evaluable Disease | Exception Radiation Field CT | Exception Radiation Field MRI

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1882536
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1882536
UMLS CUI [4,3]
C0024485
ecog performance status of 0-1.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 12 weeks.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
able to swallow and retain oral medication.
Beschreibung

Able to swallow Oral medication | Ability Retain Oral medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0175795
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of complete or partial bowel obstruction.
Beschreibung

Intestinal Obstruction Complete | Partial bowel obstruction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021843
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C1328480
gynecological cancer: all non-epithelial cancers of the ovary, fallopian tube, peritoneum, endometrium or cervix as well as neuro-endocrine tumors are excluded.
Beschreibung

Malignant Neoplasms Gynecological Without Epithelium | Neuroendocrine Tumors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0018417
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C0014609
UMLS CUI [2]
C0206754
radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) ≤ 3 weeks prior to c1d1.
Beschreibung

Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
chemotherapy, immunotherapy or systemic anticancer therapy ≤ 3 weeks prior to c1d1.
Beschreibung

Chemotherapy | Immunotherapy | Cancer treatment Systemic

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0021083
UMLS CUI [3,1]
C0920425
UMLS CUI [3,2]
C0205373
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Ähnliche Modelle

Eligibility Ovarian Carcinoma NCT02025985

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Ovarian Carcinoma | Fallopian Tube Carcinoma | Carcinoma of peritoneum | Patients Unresponsive to Platinum | Patients Resistant to Platinum | Chemotherapy Quantity Recurrent disease
Item
ovarian, fallopian tube or peritoneal carcinoma: both platinum refractory and platinum resistant patients, who have received ≥ 1 lines of chemotherapy for relapsed disease (i.e., ≥2 lines of chemotherapy in total).
boolean
C0029925 (UMLS CUI [1])
C0238122 (UMLS CUI [2])
C0948303 (UMLS CUI [3])
C0030705 (UMLS CUI [4,1])
C0205269 (UMLS CUI [4,2])
C0032207 (UMLS CUI [4,3])
C0030705 (UMLS CUI [5,1])
C0332325 (UMLS CUI [5,2])
C0032207 (UMLS CUI [5,3])
C0392920 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0277556 (UMLS CUI [6,3])
Endometrial Carcinoma | Chemotherapy Quantity | Recurrent disease TNM clinical staging | Advanced disease TNM clinical staging
Item
endometrial carcinoma: patients must have received ≥ 1 line of chemotherapy for relapsed or advanced (stage iv, iiic) disease.
boolean
C0476089 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C0679246 (UMLS CUI [4,1])
C3258246 (UMLS CUI [4,2])
Cervix carcinoma | Chemotherapy Quantity | Recurrent disease | Advanced disease TNM clinical staging
Item
cervical carcinoma: patients must have received ≥ 1 lines of chemotherapy for relapsed or advanced (stage ivb) disease.
boolean
C0302592 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3])
C0679246 (UMLS CUI [4,1])
C3258246 (UMLS CUI [4,2])
Breast Carcinoma | Breast adenocarcinoma | Neoplasm Metastasis Inappropriate Excision | Advanced disease Locally Inappropriate Excision | Neoplasm Metastasis Inappropriate Curative treatment | Advanced disease Locally Inappropriate Curative treatment
Item
breast cancer: adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection or any other curative treatment.
boolean
C0678222 (UMLS CUI [1])
C0858252 (UMLS CUI [2])
C0027627 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C0728940 (UMLS CUI [3,3])
C0679246 (UMLS CUI [4,1])
C1517927 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C0728940 (UMLS CUI [4,4])
C0027627 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C1273390 (UMLS CUI [5,3])
C0679246 (UMLS CUI [6,1])
C1517927 (UMLS CUI [6,2])
C1548788 (UMLS CUI [6,3])
C1273390 (UMLS CUI [6,4])
Breast Carcinoma | Hormone Therapy Quantity Neoplasm Metastasis | Chemotherapy Quantity Neoplasm Metastasis
Item
breast cancer: patients must have received ≥ 1 line of endocrine treatment or chemotherapy for metastatic disease as applicable for the respective breast cancer subtype.
boolean
C0678222 (UMLS CUI [1])
C0279025 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0392920 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
Breast Carcinoma | Triple Negative Breast Neoplasms | Hormone receptor positive tumor | Oestrogen receptor positive breast cancer | Progesterone receptor positive tumor | HER2 negative carcinoma of breast
Item
breast cancer: patient must have either triple negative cancer or be hormone receptor positive (i.e., er+ and/or pr+) and her2 negative.
boolean
C0678222 (UMLS CUI [1])
C3539878 (UMLS CUI [2])
C1563119 (UMLS CUI [3])
C2938924 (UMLS CUI [4])
C1562928 (UMLS CUI [5])
C2316304 (UMLS CUI [6])
Measurable Disease | Evaluable Disease | Exception Radiation Field CT | Exception Radiation Field MRI
Item
must have either measurable disease (recist 1.1) or evaluable disease outside irradiated field on ct/mri. a rise in ca-125 or other tumor marker alone is not sufficient.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1882536 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1882536 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
ECOG performance status
Item
ecog performance status of 0-1.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Able to swallow Oral medication | Ability Retain Oral medication
Item
able to swallow and retain oral medication.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Intestinal Obstruction Complete | Partial bowel obstruction
Item
evidence of complete or partial bowel obstruction.
boolean
C0021843 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1328480 (UMLS CUI [2])
Malignant Neoplasms Gynecological Without Epithelium | Neuroendocrine Tumors
Item
gynecological cancer: all non-epithelial cancers of the ovary, fallopian tube, peritoneum, endometrium or cervix as well as neuro-endocrine tumors are excluded.
boolean
C0006826 (UMLS CUI [1,1])
C0018417 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0014609 (UMLS CUI [1,4])
C0206754 (UMLS CUI [2])
Therapeutic radiology procedure
Item
radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) ≤ 3 weeks prior to c1d1.
boolean
C1522449 (UMLS CUI [1])
Chemotherapy | Immunotherapy | Cancer treatment Systemic
Item
chemotherapy, immunotherapy or systemic anticancer therapy ≤ 3 weeks prior to c1d1.
boolean
C0392920 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C0920425 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
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